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CompletedNCT03289598Updated Feb 7, 2019

Effect of Involving Community-dwelling Older Adults in Activities in Relation to Meals

An interventional study of A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals in Frail Older Adults, sponsored by The Danish Dietetic Association. Completed at 1 site in Denmark. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-02-07.

Sponsored by The Danish Dietetic Association · Not applicable, Interventional, and Health services research

Phase
Not applicable
Study type
Interventional
Enrollment
130
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study summary

Community-dwelling older adults receiving support at home such as meals-on-wheels may lose the ability to preserve social, cognitive, and functional abilities, when becoming accustomed to and dependent of community aged care. When still able to cook older adults often hold some control over the foods that are prepared and which they eat, and which helps to foster identity. The purpose of this study is to evaluate community-dwelling older adults being involved in activities in relation to meals in a rehabilitation program.

02

Conditions studied

  • Frail Older Adults
03

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Community dwelling older people (64+ years)
  • Able to eat and drink
  • Receive meals-on-wheels from the municipality at the time of recruitment
  • Live in the city of Odense

Exclusion criteria

Exclusion Criteria:

  • Moderate-severe dementia as judged by the home -care staff
  • Being deaf and/or not understand the language of Danish.
  • Not being able to sign the informed consent
  • Receiving (or likely to receive in the next 6 months) enteral tube feeding or parenteral nutrition;
  • Participating in other project in the municipality about nutritional support in the form of dietetic advice;
  • Or on an end-of-life care pathway
04

Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
130 participants (actual)

Study arms

  • Experimental
    Interventionsgroup

    Behavioral: A rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals

  • No intervention
    Controlgroup

Interventions

  • BehavioralA rehabilitation process involving collaborative goal setting with a case manager about managing own food and meals

    The intervention consists of two parts: 1. Education of the health care staff with three day's education focusing of aspects of food, meals and nutrition to old people. 2. The individual participants in the intervention group will be participating in a rehabilitation process involving collaborative goal setting with a case manager. All the case managers have a background as registered dietician and will before start of the intervention be trained in managing a rehabilitation process with focus on meals and food. The training will consist of three days of education in, respectively, areas in relation to rehabilitation and the role as a care manager. Specific topics include; assessment of functional abilities in relation to meals and food; goal setting by means of GAS (Goal Attainment Scaling), ethical considerations and communication.

05

What researchers measure

Primary outcomes

  1. Quality of life

    EuroQol (EQ-5D) is a questionnaire with five questions to be answered in three categories of movement, self-care, usual activities, pain/discomfort and anxiety/depression.

    Time frame: Up to 6 months

Secondary outcomes

  1. 30 seconds chair-stand

    30 seconds chair-stand will be used to measure muscle strength. Participants are asked to fold their arms across their chest and to stand up and sit down on a chair without pushing off with arms, as many times as possible for 30 seconds.

    Time frame: Up to 6 months

  2. Weight

    Weight in kilograms

    Time frame: Up to 6 months

  3. Height

    Height in meter and centimetre

    Time frame: Up to 6 months

  4. Loneliness

    Loneliness will be measured by the UCLA Loneliness Scale. The scale consists of 20 items (11 positive and 9 negative), describing subjective feelings of loneliness.

    Time frame: Up to 6 months

  5. Mental well-being

    Mental well-being will be measured by the short Warwich-Edinburgh Mental Well-being Scale (SWEMWBS) - Danish version 2014. SWEMWBS is a 7-item scale; each answered on a 1 to 5 Likert scale, with most items representing aspects of psychological and eudemonic well-being, and few covering hedonic well-being or affect.

    Time frame: Up to 6 months

  6. Self-efficacy

    Self-efficacy will be measured by The General Self-Efficacy Scale (GSE).The GSE is a 10-item psychometric scale will be used to assess optimistic self-beliefs to cope with a variety of difficult demands in life.

    Time frame: Up to 6 months

  7. Satisfaction with food-related life

    The satisfaction with food-related life will be measured by the Satisfaction with Food-related Life (SWFL) scale.The SWFL, consists of 5 items grouped into a single dimension (e.g. Food 1: Food and meals are positive elements; Food 2: I am generally pleased with my food; Food 3: My life in relation to food and meals is close to ideal; Food 4: With regards to food, the conditions of my life are excellent; Food 5: Food and meals give me satisfaction in daily life.). In each scale, the respondents must indicate their degree of agreement with these statements using a 6-level Likert scale (1 = disagree completely, 6 = agree completely).

    Time frame: Up to 6 months

06

Study locations

1 site
  • The Danish Dietetic Association
    Copenhagen, Denmark
07

References and documents

Publications

  • Husted MM, Beck AM, Ulrikkeholm LK. A cluster randomised feasibility pilot trial evaluating involving community-dwelling older adults in activities in relation to meals in a rehabilitation program; recruitment, data collection and protocol. Pilot Feasibility Stud. 2018 Aug 6;4:134. doi: 10.1186/s40814-018-0323-3. eCollection 2018. PubMed 30123525 ↗

Individual participant data

Plan to share: Undecided

08

Registry details

Key details

Study ID
NCT03289598
Lead sponsor
The Danish Dietetic Association
Collaborators
The Danish Meal Partnership, Ministry of Environment and Food of Denmark, Metropolitan University College, National Board of Health, Denmark, The City of Odense, Danish Diet & Nutrition Association
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Feb 15, 2017
Primary completion
Sep 1, 2018
Completion
Sep 1, 2018
Last update
Feb 7, 2019

Study contacts

Mette Pedersen
study director · The Danish Dietetic Association

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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